Regulatory Requirements Research Articles

A novel multicriteria web‐based decision support system to enhance resource allocation in energy companies: a portfolio selection with c‐optimal PROMETHEE

AbstractIn an uncertain world, decision support systems (DSSs) are essential for effective portfolio management. Electricity companies often face challenges in allocating limited resources among competing projects, influenced by sustainability and regulatory requirements. To address these challenges, multicriteria approaches have been developed, focusing on complex issues involving outranking methods. This paper introduces a methodological advance with a novel algorithm that enhances the c‐optimal PROMETHEE (Preference Ranking Organization Method for Enrichment Evaluations) approach, resolving scaling issues inherent in the PROMETHEE V method. Our key contribution is a refined procedure for efficiently identifying and comparing c‐optimal solutions while preserving the method's axiomatic integrity, ensuring the selection of the “true best” portfolio. Additionally, we present a web‐based DSS designed to implement this methodology, featuring interactive visualization and sensitivity analysis tools. Freely available online, both the algorithm and DSS were validated through a case study with a Brazilian electricity company, demonstrating their practical benefits and applicability across various business contexts.

The present scenario of artificial intelligence and machine learning in financial services: An empirical study

The financial services industry is experiencing a swift adoption of artificial intelligence (AI) and machine learning for a variety of applications. These technologies can be employed by both public and private sector entities to ensure adherence to regulatory requirements, monitor activities, evaluate data accuracy, and identify instances of fraudulent behavior. The utilization of artificial intelligence (AI) and machine learning (ML) has the potential to provide novel and unforeseen manifestations of interconnectivity within financial markets and institutions. This can be represented by the adoption of previously disparate data sources by diverse institutions. The researchers employed convenience sampling as the sampling method. The form was filled out over the period spanning from July 2023 to February 2024, and it was designed to be both anonymous and accessible through online and offline platforms. To assess the reliability and validity of the measurement scales and evaluate the structural model, we employed Partial Least Squares (PLS) for model validation. Specifically, we have used the software package Smart-PLS 3 with a bootstrapping of 5000 samples to estimate the significance of the parameters. The results indicate a positive and direct connection between artificial intelligence (AI) and either financial services or financial institutions. On the contrary, machine learning (ML) exhibits a strong and positive association among financial services and financial institutions. Similarly, there exists a positive and direct connection between AI and investors, as well as between ML and investors.

A NEW INTERNATIONAL ACCELERATOR PROGRAMME FOR NOVEL BRAIN TUMOUR THERAPIES

Abstract AIMS Developing a comprehensive translational programme for brain tumours involves navigating numerous challenges, including preclinical study robustness, safety, clinical trial design, understanding and addressing regulatory requirements, and commercialisation. Recognising the difficulty of this journey, the Brain Tumour Research Novel Therapeutics Accelerator (BTR-NTA) was launched in 2023. The BTR-NTA is an accelerator programme providing independent expert guidance to de-risk drug or device development through systematic evaluation. The international, multidisciplinary BTR-NTA Committee spans expertise across the entire therapeutic development pathway. Supported by Brain Tumour Research, BTR-NTA is free for academics and available at nominal cost for industry. METHOD Researchers at any stage of therapeutic development may apply to BTR-NTA. Accepted applicants proceed as follows: 1. Applicants complete a form highlighting their current and prospective data and findings. All materials are covered under a confidentiality agreement that protects their intellectual property; 2. Applicants’ proposals are reviewed by the BTR-NTA Committee; 3. The Applicants and BTR-NTA Committee meet in-person to constructively evaluate the work; and 4. Applicants receive a comprehensive report with feedback on strengths, identification of potential risks, and guidance on next steps. The BTR-NTA Committee dedicates time for in-person meetings with each applicant, and extensive time pre and post-meeting. RESULTS Since the launch of BTR-NTA, 13 international groups have applied to the programme and three groups have had their therapies reviewed in-person by the BTR-NTA committee to date. Of the groups who provided feedback on the programme, 100% intended to adjust or refine their future work based on the BTR-NTA Committee’s input and the average rating of the programme’s helpfulness was 9.5/10. CONCLUSION The ultimate goal of BTR-NTA is to help researchers with a potential therapy for brain tumours navigate the development journey and reach the clinic in an efficient way. This programme will support development of novel therapies to improve outcomes for brain tumour patients.

New Eco-Cements Made with Marabou Weed Biomass Ash

Biomass ash is currently attracting the attention of science and industry as an inexhaustible eco-friendly alternative to pozzolans traditionally used in commercial cement manufacture (fly ash, silica fume, natural/calcined pozzolan). This paper explores a new line of research into Marabou weed ash (MA), an alternative to better-known conventional agro-industry waste materials (rice husk, bagasse cane, bamboo, forest waste, etc.) produced in Cuba from an invasive plant harvested as biomass for bioenergy production. The study entailed full characterization of MA using a variety of instrumental techniques, analysis of pozzolanic reactivity in the pozzolan/lime system, and, finally its influence on the physical and mechanical properties of binary pastes and mortars containing 10% and 20% MA replacement content. The results indicate that MA has a very low acid oxide content and a high loss on ignition (30%) and K2O content (6.9%), which produces medium–low pozzolanic activity. Despite an observed increase in the blended mortars’ total and capillary water absorption capacity and electrical resistivity and a loss in mechanical strength approximately equivalent to the replacement percentage, the 10% and 20% MA blended cements meet the regulatory chemical, physical, and mechanical requirements specified. Marabou weed ash is therefore a viable future supplementary cementitious material.

Determining the most rational method of automooring vessels in a navigation lock chamber

The article presents the results of a study to determine the most rational method of automatic mooring of vessels in a navigation lock chamber. The relevance of the study is due to updated regulatory requirements in the field of designing the specified shipping hydraulic structures, the need to improve the efficiency and safety of navigation, including ensuring the passage of unmanned vessels, as well as the lack of ready-made technical solutions for their installation on the structures in question. To solve this problem, the authors of the study used the method of expert assessments, which allows taking into account the opinions and experience of specialists in the field of shipping, which ensures a more objective and reasonable choice of the most rational method of automatic mooring. As a method of expert assessment, taking into account the issues under consideration, the method of point assessments was chosen. For this purpose, during the study, a survey was conducted among the involved experts, during which each of them gave his intuitionistic assessment. In this study, vacuum, electromagnetic and lever-andhinge devices are considered as methods of automatic mooring. The criteria considered include, among other things, the need to reconstruct the lock chamber, environmental friendliness, the ability to hold the vessel, the complexity of the device, and reliability indicators. As a result of collecting and processing the obtained data, it was found that the most preferable method of auto-mooring of vessels in the lock chamber is a vacuum device. The results obtained indicate the feasibility of developing and implementing vacuum auto-mooring devices on shipping hydraulic structures. The results of the study are of practical interest to specialists in the field of shipping and can be used in the design and reconstruction of navigation locks.

FBrake, a Method to Simulate the Brake Efficiency of Laden Light Passenger Vehicles in PTIs While Measuring the Braking Forces of Their Unladen Configurations

This study introduces fBrake, a novel simulation method now designed for use in periodic technical inspections of M1 and N1 vehicle categories, addressing challenges posed by Directive 2014/45/EU. The directive mandates that braking efficiency must be measured relative to the vehicle’s maximum mass, which often results in underperformance during inspections due to vehicles typically being unladen. This discrepancy arises because the maximum braking forces are proportional to the vertical load on the wheels, causing empty vehicles to lock their wheels prematurely compared to laden ones. fBrake simulates the braking forces of unladen vehicles to reflect a laden state by employing an optimal brake-force distribution curve that aligns with the vehicle’s inherent braking behavior, whether through proportioning valves or through electronic brake distribution systems in anti-lock-braking-system-equipped vehicles. Our methodology, previously applied to heavy vehicles, involved extensive experimentation with a roller brake tester, comparing the actual braking performances of dozens of vehicles to those of their simulated counterparts using fBrake. The results demonstrate that fBrake reliably replicates the braking efficiency of laden vehicles, validating its use as an accurate and effective tool for braking system assessments in periodic inspections, irrespective of the vehicle’s load condition during the test. This approach ensures compliance with regulatory requirements while enhancing the reliability and safety of vehicle inspections.

Establishing a multi-method approach for unprecedented detection and quantification of 13 genotoxic impurities (GTIs) in Apixaban drug substance through ultra-performance liquid chromatography (UPLC).

This groundbreaking study introduces a pioneering development of multi-method approach for the first-ever detection and quantification of 13 genotoxic impurities (GTIs) in Apixaban (Apx) drug substance using ultra-performance liquid chromatography (UPLC) with ultraviolet (UV) detector. In this novel endeavor, two distinct UPLC-UV methods, Method A (for impurities A to G) and Method B (for impurities H to M), were meticulously developed and validated as per International Council for Harmonization (ICH) guidelines to address the challenge of identification and control of 13 GTIs in Apx drug substance. The validation process included rigorous assessment of linearity, accuracy, specificity, precision, limit of quantification (LOQ), and limit of detection (LOD) for each impurity in each method which marks a significant advancement in pharmaceutical analysis. The developed methods address the regulatory requirements set forth by ICH M7(R2) guidelines by providing a reliable approach for quantifying GTIs in Apx drug substance at trace levels to minimize the potential carcinogenic risk to the patients.

Economic legal personality of virtual assets service providers: concept and elements

The objective of the study is to provide substantiation for proposals to clarify the definition of the concept and elements of economic legal personality of virtual assets service providers. In light of the findings presented in the study, the author concludes that economic legal personality of service providers related to the circulation of virtual assets is the ability of service providers related to the circulation of virtual assets to be parties to economic legal relations - to participate in legal relations arising in the field of business through the exercise of economic competence (rights and obligations determined by law) and economic legal capacity (rights and obligations acquired voluntarily due to the need to carry out economic activities and enshrined in the relevant documents). In terms of their economic legal personality, virtual assets service providers are characterized by two key elements: economic competence and economic legal capacity. The moment when the general legal personality of service providers related to the turnover of virtual assets arises is the state registration of a business entity as a legal entity. In contrast, special legal personality will arise only after obtaining a permit, since the activities of service providers related to the turnover of virtual assets are subject to specific regulatory requirements. The provision of services related to the turnover of virtual assets is permitted only if a specific permit has been obtained, in accordance with the stipulations set forth in the Law of Ukraine «On Virtual Assets» (part 2 of Article 18). It has been determined that virtual assets service providers possess exclusive economic legal personality, encompassing an exhaustive list of permissible activities. These entities may only engage in activities authorized by the Law of Ukraine «On Virtual Assets,» upon acquiring the relevant permits. It may be inferred that obtaining such a permit simultaneously entails the prohibition against engaging in alternative business endeavors.

AI in Business Aviation Route Optimization: Reducing Fuel Consumption and Environmental Impact

Purpose: This paper reviews ways that artificial intelligence could be used to make business aviation operations most fuel-efficient, cheapest in cost of operation, and smallest in terms of ecological footprint. The research elaborated possible ways of using AI in the spheres of flight planning, predictive maintenance, fuel management, emission tracking, and compliance in business aviation. Methodology: It was also empirical case-study-oriented research that investigated the impacts of AI-driven technologies on business aviation operators, basically NetJets, VistaJet, and Flexjet. The impacts are from route optimization to predictive maintenance, fuel management, and compliance with regulations. Information such as fuel consumption, CO2 emissions, and operational efficiency was obtained before and after the adoption of AI technologies. Findings: The fuel savings from AI-driven systems are reaching a point of salience, at 9 to 14% in the various cases, with associated reductions in CO2 emissions. AI-powered predictive maintenance resulted in a 20% reduction in unscheduled events, thereby bettering the availability of fleets. Artificial intelligence increased overall efficiency and improved decisions for in-flight, real-time operations management while conforming to regulatory requirements in reporting. Additionally, AI is going to bring tremendous values in optimizing SAFs and aircraft energy-efficient technology to make flying sustainable. Unique Contribution to Theory, Policy, and Practice: This work contributes to AI in aviation by demonstrating its practical application in reducing environmental impacts and operational costs in business aviation. It provides a framework for integrating AI into aviation management systems and highlights the importance of public-private cooperation for wider AI adoption. The findings are valuable for policymakers, business aviation operators, and industry leaders aiming to advance sustainability and regulatory compliance

Analyzing the Chiral Purity of Pharmaceuticals: The Application of Cyclodextrin-Based Chiral Selectors in Capillary Electrophoresis

The current review provides a focused analysis of the application of capillary electrophoresis (CE) techniques to determine the chiral purity of pharmaceuticals, with a specific emphasis on cyclodextrin- (CD) based chiral selectors (CSs), highlighting advancements, methodologies, and trends in this area as reported in studies published from 2010 to 2024. The review emphasizes CE’s evolution as a critical tool in this field, discussing its advantages, such as high efficiency, flexibility, relatively low costs, and minimal environmental impact, which make it well-suited for modern pharmaceutical applications. Additionally, it underscores the importance of CE in meeting stringent regulatory requirements for chiral drug substances. A significant shift in method optimization has occurred in the last ten years, shifting from the traditional One-Factor-at-a-Time (OFAT) strategy to the Design-of-Experiments (DoE) approach; this shift has enabled more systematic and robust method development. Furthermore, a common trend in recent years is the application of Quality-by-Design (QbD) principles in method development and optimization, ensuring higher reliability and efficiency. Additionally, there is an increasing focus on developing CE methods capable of detecting both achiral and chiral impurities simultaneously, which enhances the comprehensiveness of the analysis. This review seeks to guide future research and development in optimizing CE methodologies for pharmaceutical applications.

Cryptocurrency Portfolio Allocation under Credibilistic CVaR Criterion and Practical Constraints

The cryptocurrency market offers attractive but risky investment opportunities, characterized by rapid growth, extreme volatility, and uncertainty. Traditional risk management models, which rely on probabilistic assumptions and historical data, often fail to capture the market’s unique dynamics and unpredictability. In response to these challenges, this paper introduces a novel portfolio optimization model tailored for the cryptocurrency market, leveraging a credibilistic CVaR framework. CVaR was chosen as the primary risk measure because it is a downside risk measure that focuses on extreme losses, making it particularly effective in managing the heightened risk of significant downturns in volatile markets like cryptocurrencies. The model employs credibility theory and trapezoidal fuzzy variables to more accurately capture the high levels of uncertainty and volatility that characterize digital assets. Unlike traditional probabilistic approaches, this model provides a more adaptive and precise risk management strategy. The proposed approach also incorporates practical constraints, including cardinality and floor and ceiling constraints, ensuring that the portfolio remains diversified, balanced, and aligned with real-world considerations such as transaction costs and regulatory requirements. Empirical analysis demonstrates the model’s effectiveness in constructing well-diversified portfolios that balance risk and return, offering significant advantages for investors in the rapidly evolving cryptocurrency market. This research contributes to the field of investment management by advancing the application of sophisticated portfolio optimization techniques to digital assets, providing a robust framework for managing risk in an increasingly complex financial landscape.

MediGate: a MedTech product innovation development process from university research to successful commercialization within emerging markets

This study proposes a comprehensive MedTech product innovation development framework tailored for university research commercialization within emerging markets. The MediGate framework, built on the Augmented Stage-Gate model, addresses the unique challenges of MedTech innovation, including regulatory compliance, stakeholder engagement, and market dynamics. The framework integrates critical decision-making criteria for different types of inventions to drive academic research toward commercialization in clinical settings. Through detailed case studies, including innovations like albumin strip test, 3D-printed patient-specific implant, COVID-19 nasal spray, and AI platform for depression detection, and iterative refinement, the framework provides actionable guidelines for navigating the complexities of product development. These guidelines ensure alignment with clinical needs, regulatory requirements, and market strategies. The research highlights the importance of early-stage valuation, reimbursement strategies, legal and IP considerations, and manufacturing and quality management. By offering a structured pathway, this research contributes to the theoretical and practical understanding of MedTech commercialization, aiming to enhance innovation success and healthcare impact in emerging markets.

Treasury Bill Investment and Financial Performance of Tier Three Commercial Banks in Kenya

Purpose: Bank tier categorization is determined by size, complexity, and regulatory requirements, with criteria varying by country and authority (CBK, 2020). Tier 3 banks are the smallest, providing basic services to individuals and small businesses (CBK, 2020). This study investigated the impact of Treasury bill investment on the financial performance of Tier 3 commercial banks in Kenya. Methodology: This study was grounded on the theory of Capital Asset Pricing. The study used secondary data from the Central Bank of Kenya and audited financial statements from 2015 to 2022. Focusing on Return on Assets, the findings aimed to help Tier 3 banks optimize financial performance. Findings: Results showed that investing in treasury bills significantly improved financial performance of tier three commercial banks. Unique Contribution to Theory, Practice and Policy: The study recommended that policy makers should come up with policies that favor allocating more investment capital towards Treasury bill investment so that banks may seize opportunities to optimize their investment strategies and consequently strengthen their overall financial performance in the market.

A new method to evaluate fluoroscopic system collimator performance.

Fluoroscopy uses collimators to limit the radiation field size. Collimators are often evaluated annually during equipment performance evaluations to maintain compliance with regulatory and/or accreditation bodies. A method to evaluate and quantify fluoroscopy collimator performance was developed. A radiation field and displayed image measurement device consisting of radiopaque rulers and radiochromic film strips was placed on the x-ray source assembly exit window to evaluate fluoroscopy collimator performance. This method was used to evaluate collimator performance on 79 fluoroscopic imaging systems including fixed C-arms, mobile C-arms, mini C-arms, and radiographic fluoroscopic systems. The excess length (EL), excess width (EW), and sum EL + EW of the radiation field relative to the displayed image were measured and compared to the limits specified in 21CFR1020.32. Four systems exceeded these limits. Placing the radiation measurement device at the x-ray source assembly exit window relative to the image receptor cover increased the film exposure rate by a factor up to 14.6. The time required to set up and complete the fluoroscopy collimator performance measurements using this method ranged from 5 to 10 min. This method provides an easily implemented quantitative measure of fluoroscopy system collimator performance that satisfies regulatory and accreditation body requirements.

Проблемні питання забезпечення якості дорожньо-будівельних матеріалів та виробів в контексті особливостей їх сертифікації в Україні відповідно до ДСТУ EN ISO/IEC 17065:2019 та закону України «Про надання будівельної продукції на ринку»

Introduction. The article examines the importance of certification of road construction materials as one of the main tools for ensuring their quality. Problems. The authors emphasize that the certificate of conformity is a key document that confirms that the products meet the established regulatory requirements. Product certification, which includes laboratory tests and control of the production process, ensures the objectivity of quality assessment. The article describes in detail the stages of the certification process, from submitting an application to technical supervision of certified products. The role of certification bodies, which must be accredited by the National Accreditation Agency of Ukraine (NAAU), is emphasized separately, and their responsibility for the safety and quality of certified road construction materials is also noted. The authors also draw attention to the problem of non-compliance with the quality standards of road construction products in Ukraine, which leads to road defects, such as cracks and subsidence, which can appear already a year after the road is put into operation. In this context, it is emphasized the need to strengthen the quality control of both produced in Ukraine and imported road construction materials. The article also considers the issue of voluntary certification of road construction products, which is carried out at the initiative of the manufacturer or supplier, which is becoming more and more important in the conditions of tender procurement. At the same time, the lack of quality control of products sold through retail networks and the lack of effective quality control of imported road construction materials are emphasized.

Regulatory requirements to support a specific regulation of oil norm waste in Brazil.

The oil and natural gas industry is one of the largest producers of Naturally Occurring Radioactive Material (NORM) worldwide. The scale and sludge are NORM wastes with the highest activity concentration levels, reaching 3500Bq per g of 226Ra (scale). As wastes (sludge, scale, and produced water) are constantly produced in routine activities, a specific regulation for these wastes is necessary. Therefore, this study presents the regulatory requirements that may serve as a basis for the responsible regulatory body to prepare a specific regulation for the NORM waste generated by the oil industry. As a study published showing that the disposal of bulk NORM waste (not packaged wastes) is viable in Brazil, requirements for the management of these wastes and the characteristics of the landfill for disposal were included.

The Concept of Building an Integrated Digital Ecosystem to Improve the Quality of Products and Services of Defense Industry Enterprises

Research and development of systems for managing material, technical, and intellectual resources are key directions for improving manufacturing processes in the modern world. In recent years, the question of integrating various management systems has become particularly relevant due to the widespread adoption of quality management systems and their certification to meet current regulatory requirements. This study attempts to merge the advantages of using product lifecycle information support technologies, such as data and information management, with the concept of digital twins, including virtual design, digital product modeling, and real-time analysis. The analysis covers the constituent elements of the generalized product design and manufacturing process, addressing the construction of an integrated digital ecosystem to enhance the quality of products and services in the defense-industrial complex. This ecosystem is based on the integration of technologies for continuous product information support using their digital twins and an integrated quality management system. It is shown that the approach to evaluating the effectiveness of purposeful processes should be complemented by a risk-oriented model, which includes response scenarios to potential adverse effects of the operation of the purposeful organizational-technical system. A structural scheme and formalized description of a generalized product information support model are presented, allowing for the integration of specific quality indicators into a unified strategic outcome. Ultimately, a concept for building an integrated digital ecosystem for defense-industrial enterprises is proposed, aimed at enhancing the overall quality of products and services.

How Well Are We Protecting Human Research Subjects?

Protecting human research subjects is an ethical mandate for all contemporary research involving human subjects. From 1974 to 1999, we had the institutional review board (IRB) system and the Common Rule, but realized that in addition to IRBs, investigators, institutions, sponsors of research, research participants, and the government, all share responsibilities in protecting human research subjects. Starting 2000, institutions established human research protection programs to ensure the rights and welfare of research participants and to meet human research ethical and regulatory requirements. Some institutions had their human research protection programs further accredited to ensure rigorous standards for quality and protection. In 2018, the Common Rule was extensively revised to modernize the regulations by enhancing protections and reducing burden for researchers. However, throughout these periods, we did not know how well we were protecting human research subjects, because we did not know how to measure human research subject protections. With the publication of human research subject protections performance metrics in 2023, it becomes possible for the first time to assess quantitatively how well we are protecting human research subjects. Research institutions can now monitor the effectiveness of their human research protection programs and identify areas of vulnerability for quality improvement. We should also be able to determine how well human research protection programs are doing in protecting human research subjects; determine whether external accreditation improves human research subject protections and whether the revised Common Rule in fact leads to enhanced protections; and identify prospectively which procedures or interventions can enhance human research subject protections.

New Active Ingredients for Sustainable Modern Chemical Crop Protection in Agriculture.

Today, the agrochemical industry faces enormous challenges to ensure the sustainable supply of high-quality food, efficient water use, low environmental impact, and the growing world population. The shortage of agrochemicals due to consumer perception, changing needs of farmers and ever-changing regulatory requirements is higher than the number of active ingredients that are placed on the market. The introduction of halogen atoms into an active ingredient molecule offers the opportunity to optimize its physico-chemical properties such as molecular lipophilicity. As early as 2010, around four-fifths of modern agrochemicals on the market contained halogen atoms. In addition, it becomes clear that modern agrochemicals have increasingly complex molecular structures with one or more stereogenic centers in the molecule. Today, almost half of modern agrochemicals are chiral molecules (herbicides, insecticides/acaricides/nematicides ≪ fungicides) and most of them consist of mixtures such as racemic mixtures of enantiomers, followed by mixtures of diastereomers and mixtures of pure enantiomers. Therefore, it is important that halogen-containing substituents or stereogenic centers are considered in the structural optimization of the active ingredients to ultimately develop sustainable agrochemicals in terms of efficacy, ecotoxicology, ease of use and cost-effectiveness.

Problems of management of patient biological waste in radionuclide diagnostics

Biological excretion from patients (urine) generated during radionuclide diagnostics enters directly into the hospital sewage system. The establishment of new clearance level according to Resolution of the Government of the Russian Federation No. 1069 of October 19, 2012 may entail amendments to regulatory documents for radionuclide diagnostics departments. One of these requirements is a mandatory dedicated sewage system. Establishment of the requirement may lead to an increase the cost of the radionuclide diagnostic examinations, and to a decrease the accessibility of radionuclide diagnostic. The aim of this study was to estimate the activity of radionuclides in patient urine after radionuclide diagnostic and activity concentration in sewage water in the hospital and in the transport tank of toilet for evaluation of paths of waste manage. Based on published literature data, models of biological excretion were constructed for the following radiopharmaceuticals: 99mTc-pyrophosphate, 64Cu-Labeled Monoclonal Antibody, 18F-FDG, 68Ga-PSMA-617. The activity of radionuclides in the patient waste in the hospital and in public transport during the patient transportation to home was calculated. Various scenarios of patient transportation were considered. The values of the excreted activity, activity concentration and dose rate at 1 m from the tank with sewage water for each type of transport were calculated. The calculated values of the radionuclide activity concentration in sewage water in transport tank of toilet for the majority scenarios exceed the clearance level (up to 180 times for 68Ga-PSMA-617 when traveling by bus). According the regulatory requirements, it is necessary to collect patient excretions after radionuclide diagnostic examinations and hold it for decay. However, estimated effective doses of individuals from the public from contact with biological patient waste do not exceed the acceptable value. This is due to the short half-life of diagnostic radionuclides. The paths of management system of biological patient waste were proposed.